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Volumn 6, Issue 4, 2011, Pages 401-419

Experimental heterogeneity and standardisation: Stem cell products and the clinical trial process

Author keywords

cells as drugs; clinical trials; ectopic life; regenerative medicine

Indexed keywords


EID: 81255179201     PISSN: 17458552     EISSN: 17458560     Source Type: Journal    
DOI: 10.1057/biosoc.2011.17     Document Type: Article
Times cited : (27)

References (53)
  • 2
    • 0033513981 scopus 로고    scopus 로고
    • Rethinking transparency and accountability in medicines regulation in the United Kingdom
    • Abraham, J., Sheppard, J. and Reed, T. (1999) Rethinking transparency and accountability in medicines regulation in the United Kingdom. British Medical Journal 318(7175): 46-47. (Pubitemid 29188903)
    • (1999) British Medical Journal , vol.318 , Issue.7175 , pp. 46-47
    • Abraham, J.1    Sheppard, J.2    Reed, T.3
  • 3
    • 81255146670 scopus 로고    scopus 로고
    • Stem-cell hope put on hold by US regulator. The Guardian (online version), 10 January, accessed 12 November 2010
    • Barriaux, M. (2007) Stem-cell hope put on hold by US regulator. The Guardian (online version), 10 January, http://www.guardian.co.uk/business/2007/ jan/10/usnews.genetics, accessed 12 November 2010.
    • (2007)
    • Barriaux, M.1
  • 5
    • 85055407549 scopus 로고    scopus 로고
    • The trouble with embryos
    • Baylis, F. and Krahn, T. (2009) The trouble with embryos. Science Studies 22(2): 31-54.
    • (2009) Science Studies , vol.22 , Issue.2 , pp. 31-54
    • Baylis, F.1    Krahn, T.2
  • 6
    • 19744379343 scopus 로고    scopus 로고
    • Stem cell therapy: Hope or hype?
    • Braude, P., Minger, S. and Warwick, R. (2005) Stem cell therapy: Hope or hype? British Medical Journal 330(7501): 1159-1160. (Pubitemid 40745036)
    • (2005) British Medical Journal , vol.330 , Issue.7501 , pp. 1159-1160
    • Braude, P.1    Minger, S.L.2    Warwick, R.M.3
  • 7
    • 0036093691 scopus 로고    scopus 로고
    • The economy of qualities
    • DOI 10.1080/03085140220123126
    • Callon, M., Méadel, C. and Rabeharisoa, V. (2002) The economy of qualities. Economy and Society 31(2): 194-217. (Pubitemid 34526907)
    • (2002) Economy and Society , vol.31 , Issue.2 , pp. 194-217
    • Callon, M.1    Meadel, C.2    Rabeharisoa, V.3
  • 8
    • 33645753762 scopus 로고    scopus 로고
    • Legal and ethical issues associated with patient recruitment in clinical trials
    • Caulfield, T. (2005) Legal and ethical issues associated with patient recruitment in clinical trials. Health Law Review 13(2-3): 58-61.
    • (2005) Health Law Review , vol.13 , Issue.2-3 , pp. 58-61
    • Caulfield, T.1
  • 9
    • 68449090072 scopus 로고    scopus 로고
    • The stem cell research environment: A patchwork of patchworks
    • Caulfield, T. et al (2009) The stem cell research environment: A patchwork of patchworks. Stem Cell Reviews and Reports 5(2): 82-88.
    • (2009) Stem Cell Reviews and Reports , vol.5 , Issue.2 , pp. 82-88
    • Caulfield, T.1
  • 11
    • 0346727086 scopus 로고    scopus 로고
    • Narrative infrastructure in product creation processes
    • Deuten, J. and Rip, A. (2000) Narrative infrastructure in product creation processes. Organization 7(1): 69-93.
    • (2000) Organization , vol.7 , Issue.1 , pp. 69-93
    • Deuten, J.1    Rip, A.2
  • 13
    • 52949153262 scopus 로고    scopus 로고
    • The rise of 'recruitmentology': Clinical research, racial knowledge, and the politics of inclusion and difference
    • Epstein, S. (2008) The rise of 'recruitmentology': Clinical research, racial knowledge, and the politics of inclusion and difference. Social Studies of Science 38(5): 801-832.
    • (2008) Social Studies of Science , vol.38 , Issue.5 , pp. 801-832
    • Epstein, S.1
  • 14
    • 84861652237 scopus 로고    scopus 로고
    • Standardising the unknown: Practicable pluripotency as doable futures
    • Eriksson, L. and Webster, A. (2008) Standardising the unknown: Practicable pluripotency as doable futures. Science as Culture 17(1): 57-69.
    • (2008) Science as Culture , vol.17 , Issue.1 , pp. 57-69
    • Eriksson, L.1    Webster, A.2
  • 15
    • 68849095962 scopus 로고    scopus 로고
    • Transplantation tolerance in an age of induced pluripotency
    • Fairchild, P.J. (2009) Transplantation tolerance in an age of induced pluripotency. Current Opinion in Organ Transplantation 14(4): 321-325.
    • (2009) Current Opinion in Organ Transplantation , vol.14 , Issue.4 , pp. 321-325
    • Fairchild, P.J.1
  • 16
    • 81255175807 scopus 로고    scopus 로고
    • Fierce Biotech. ReNeuron regulatory update. accessed 19 March 2008
    • Fierce Biotech. (2008) ReNeuron regulatory update. http://www. fiercebiotech.com/press-releases/ reneuron-regulatory-update-0, accessed 19 March 2008.
    • (2008)
  • 17
    • 67649995222 scopus 로고    scopus 로고
    • FDA regulation of stem-cell based products
    • Fink, D. (2009) FDA regulation of stem-cell based products. Science 324(5935): 1662-1663.
    • (2009) Science , vol.324 , Issue.5935 , pp. 1662-1663
    • Fink, D.1
  • 21
    • 70349730616 scopus 로고    scopus 로고
    • Pragmatic objectivity and the standardization of engineered tissues
    • Hogle, L. (2009) Pragmatic objectivity and the standardization of engineered tissues. Social Studies of Science 39(5): 717-742.
    • (2009) Social Studies of Science , vol.39 , Issue.5 , pp. 717-742
    • Hogle, L.1
  • 22
    • 81255209760 scopus 로고    scopus 로고
    • ISSCR. ISSCR guidelines for the clinical translation of stem cells. International Society for Stem Cell Research, accessed 20 January 2009
    • ISSCR. (2008) ISSCR guidelines for the clinical translation of stem cells. International Society for Stem Cell Research, http://www.isscr.org// clinical-trans/pdfs/ISSCRGLClinicalTrans.pdf, accessed 20 January 2009.
    • (2008)
  • 24
    • 54549090848 scopus 로고    scopus 로고
    • The fetal tissue economy: From the abortion clinic to the stem cell laboratory
    • Routledge. Kent, J. (2008) The fetal tissue economy: From the abortion clinic to the stem cell laboratory. Social Science and Medicine 67(11): 1747-1756.
    • (2008) Social Science and Medicine , vol.67 , Issue.11 , pp. 1747-1756
    • Routledge. Kent, J.1
  • 25
  • 27
    • 67649939164 scopus 로고    scopus 로고
    • Medical innovation versus stem cell tourism
    • Lindvall, O. and Hyun, I. (2009) Medical innovation versus stem cell tourism. Science 324(5935): 1664-1665.
    • (2009) Science , vol.324 , Issue.5935 , pp. 1664-1665
    • Lindvall, O.1    Hyun, I.2
  • 29
    • 84861652308 scopus 로고    scopus 로고
    • From bedside to bench? Communities of promise, translational research and the making of blood stem cells
    • Martin, P., Brown, N. and Kraft, A. (2008) From bedside to bench? Communities of promise, translational research and the making of blood stem cells. Science as Culture 17(1): 29-41.
    • (2008) Science as Culture , vol.17 , Issue.1 , pp. 29-41
    • Martin, P.1    Brown, N.2    Kraft, A.3
  • 30
    • 38449092179 scopus 로고    scopus 로고
    • A brief definition of regenerative medicine
    • DOI 10.2217/17460751.3.1.1
    • Mason, C. and Dunnill, P. (2008) A brief definition of regenerative medicine. Regenerative Medicine 3(1): 1-5. (Pubitemid 351541190)
    • (2008) Regenerative Medicine , vol.3 , Issue.1 , pp. 1-5
    • Mason, C.1    Dunnill, P.2
  • 31
    • 45549090538 scopus 로고    scopus 로고
    • An overview of 'the guideline for clinical research using human stem cells
    • Matsuyama, A. (2008) An overview of 'the guideline for clinical research using human stem cells'. Nippon Rinsho 66(5): 843-849.
    • (2008) Nippon Rinsho , vol.66 , Issue.5 , pp. 843-849
    • Matsuyama, A.1
  • 32
    • 70349737682 scopus 로고    scopus 로고
    • Regulatory objectivity in action: Mild cognitive impairment and the collective production of uncertainty
    • Moreira, T., May, C. and Bond, J. (2009) Regulatory objectivity in action: Mild cognitive impairment and the collective production of uncertainty. Social Studies of Science 39(5): 665-690.
    • (2009) Social Studies of Science , vol.39 , Issue.5 , pp. 665-690
    • Moreira, T.1    May, C.2    Bond, J.3
  • 35
    • 39149108841 scopus 로고    scopus 로고
    • Stem Cell Biotech: Seeking a Piece of the Action
    • DOI 10.1016/j.cell.2008.02.004, PII S0092867408002031
    • Parson, A. (2008) Stem cell biotech: Seeking a piece of the action. Cell 132(4): 511-513. (Pubitemid 351253696)
    • (2008) Cell , vol.132 , Issue.4 , pp. 511-513
    • Parson, A.B.1
  • 36
    • 54149105039 scopus 로고    scopus 로고
    • Cellular therapies for heart disease: Unveiling the ethical and public policy challenges
    • Raval, A., Kamp, T. and Hogle, L. (2008) Cellular therapies for heart disease: Unveiling the ethical and public policy challenges. Journal of Molecular and Cellular Cardiology 45(4): 593-601.
    • (2008) Journal of Molecular and Cellular Cardiology , vol.45 , Issue.4 , pp. 593-601
    • Raval, A.1    Kamp, T.2    Hogle, L.3
  • 37
    • 81255175805 scopus 로고    scopus 로고
    • ReNeuron completes IPO and raises 9.5 million
    • Scrip
    • Scrip. (2005) ReNeuron completes IPO and raises 9.5 million. Scrip 3080: 6.
    • (2005) Scrip , vol.3080 , pp. 6
  • 38
    • 60749105605 scopus 로고    scopus 로고
    • Cell therapies: Realizing the potential of this new dimension to medical therapeutics
    • Singh, P. and Williams, D. (2008) Cell therapies: Realizing the potential of this new dimension to medical therapeutics. Journal of Tissue Engineering and Regenerative Medicine 2(6): 307-319.
    • (2008) Journal of Tissue Engineering and Regenerative Medicine , vol.2 , Issue.6 , pp. 307-319
    • Singh, P.1    Williams, D.2
  • 40
    • 0037044406 scopus 로고    scopus 로고
    • Repair of infarcted myocardium by autologous intracoronary mononuclear bone marrow cell transplantation in humans
    • DOI 10.1161/01.CIR.0000034046.87607.1C
    • Strauer, B. et al (2002) Repair of infarcted myocardium by autologous intracoronary mononuclear bone marrow cell transplantation in humans. Circulation 106(15): 1913-1918. (Pubitemid 35176294)
    • (2002) Circulation , vol.106 , Issue.15 , pp. 1913-1918
    • Strauer, B.E.1    Brehm, M.2    Zeus, T.3    Kostering, M.4    Hernandez, A.5    Sorg, R.V.6    Kogler, G.7    Wernet, P.8
  • 41
    • 0037180517 scopus 로고    scopus 로고
    • Human endothelial progenitor cells from type II diabetics exhibit impaired proliferation, adhesion, and incorporation into vascular structures
    • DOI 10.1161/01.CIR.0000039526.42991.93
    • Tepper, O. et al (2002) Human endothelial progenitor cells from type II diabetics exhibit impaired proliferation, adhesion, and incorporation into vascular structures. Circulation 106(22): 2781-2786. (Pubitemid 35396976)
    • (2002) Circulation , vol.106 , Issue.22 , pp. 2781-2786
    • Tepper, O.M.1    Galiano, R.D.2    Capla, J.M.3    Kalka, C.4    Gagne, P.J.5    Jacobowitz, G.R.6    Levine, J.P.7    Gurtner, G.C.8
  • 42
    • 0032491416 scopus 로고    scopus 로고
    • Embryonic stem cell lines derived from human blastocysts
    • Thomson, J.A. et al (1998) Embryonic stem cell lines derived from human blastocysts. Science 282(5391): 1145-1147. (Pubitemid 28516247)
    • (1998) Science , vol.282 , Issue.5391 , pp. 1145-1147
    • Thomson, J.A.1
  • 45
    • 70349607884 scopus 로고    scopus 로고
    • Product regulation and the clinical translation of stem cell research
    • von Tigerstrom, B. (2009) Product regulation and the clinical translation of stem cell research. Stem Cell Reviews and Reports 5(2): 135-139.
    • (2009) Stem Cell Reviews and Reports , vol.5 , Issue.2 , pp. 135-139
    • Von Tigerstrom, B.1
  • 46
    • 85050783512 scopus 로고    scopus 로고
    • An elusive evidence base: The construction and governance of randomized controlled trials
    • Wahlberg, A. and McGoey, L. (2007) An elusive evidence base: The construction and governance of randomized controlled trials. BioSocieties 2(1): 1-10.
    • (2007) BioSocieties , vol.2 , Issue.1 , pp. 1-10
    • Wahlberg, A.1    McGoey, L.2
  • 47
    • 77950166110 scopus 로고    scopus 로고
    • From reproductive work to regenerative labour: The female body and the stem cell industries
    • Waldby, C. and Cooper, M. (2010) From reproductive work to regenerative labour: The female body and the stem cell industries. Feminist Theory 11(1): 3-22.
    • (2010) Feminist Theory , vol.11 , Issue.1 , pp. 3-22
    • Waldby, C.1    Cooper, M.2
  • 49
    • 45849108377 scopus 로고    scopus 로고
    • Governance-by-standards in the field of stem cells: Managing uncertainty in the world of "basic innovation"
    • DOI 10.1080/14636770802077009, PII 794302343
    • Webster, A. and Eriksson, L. (2008) Governance-by-standards in the field of stem cells: Managing uncertainty in the world of 'basic innovation'. New Genetics and Society 27(2): 99-111. (Pubitemid 351882343)
    • (2008) New Genetics and Society , vol.27 , Issue.2 , pp. 99-111
    • Webster, A.1    Eriksson, L.2
  • 50
    • 81255146653 scopus 로고    scopus 로고
    • Keynote presentation at the REMEDiE International Conference Bringing Regenerative Medicine to the Clinic: Trials and Tribulations in Europe and Beyond; 18-19 April, Bilbao, Spain
    • Whitaker, M. (2011) Stem cell therapies: To the clinic through the clinic. Keynote presentation at the REMEDiE International Conference Bringing Regenerative Medicine to the Clinic: Trials and Tribulations in Europe and Beyond; 18-19 April, Bilbao, Spain.
    • (2011) Stem cell therapies: To the clinic through the clinic
    • Whitaker, M.1
  • 51
    • 85044880059 scopus 로고    scopus 로고
    • The alchemy of clinical trials
    • Will, C. (2007) The alchemy of clinical trials. BioSocieties 2(1): 85-99.
    • (2007) BioSocieties , vol.2 , Issue.1 , pp. 85-99
    • Will, C.1
  • 52
    • 70249140951 scopus 로고    scopus 로고
    • Identifying effectiveness in 'The Old Old': Principles and values in the age of clinical trials
    • Will, C. (2009) Identifying effectiveness in 'The Old Old': Principles and values in the age of clinical trials. Science, Technology, & Human Values 34(5): 607-628.
    • (2009) Science, Technology, & Human Values , vol.34 , Issue.5 , pp. 607-628
    • Will, C.1
  • 53
    • 65649147929 scopus 로고    scopus 로고
    • A history lesson for stem cells
    • Wilson, J.M. (2009) A history lesson for stem cells. Science 324(5928): 727-728.
    • (2009) Science , vol.324 , Issue.5928 , pp. 727-728
    • Wilson, J.M.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.